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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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Yes – De-identified individual participant data (IPD), including demographic data, primary and secondary outcome measures, and relevant statistical data, will be shared upon reasonable request. Data will be available after publication of the main results. Researchers interested in accessing the data must submit a methodologically sound research proposal and obtain approval from the principal investigator. Data will be shared via secure electronic platforms while ensuring confidentiality.
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When the data will become available and for how long
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Access to de-identified participant data (including demographic information, primary and secondary outcomes, and relevant statistical data) will begin 6 months after publication of the main results and will remain available for a period of 5 years.
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To whom data/document is available
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Access will be granted to qualified researchers from academic institutions, research centers, and industry who submit a methodologically sound research proposal. All requests must be approved by the principal investigator.
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Under which criteria data/document could be used
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The data and related documents may only be used for scientific and research purposes; any commercial or unauthorized use is strictly prohibited. Use of the data must align with an approved research proposal and comply with ethical research standards. Permitted analyses include secondary statistical analyses and meta-analyses that contribute to scientific knowledge. Applicants must submit a formal request including a methodologically sound research proposal, an official request letter, and a confidentiality agreement. All requests will be reviewed and approved by the principal investigator before data access is granted.
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From where data/document is obtainable
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Requests for data or documents should be directed to the Principal Investigator. Email is the preferred method of contact.
Contact information is as follows: Abdolazim Shahroie
azim.shahroiee@yahoo.com
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What processes are involved for a request to access data/document
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Requests for data or documents follow a structured process as outlined below:
1. Submit a formal request via email to the Principal Investigator, including:
A methodologically sound research proposal;
An official request letter; A signed confidentiality agreement.
2. Review of the request by the research team for scientific, ethical, and technical suitability (within 2 to 4 weeks).
3. Notification of decision and, if approved, preparation of a Data Access Agreement.
4. Transfer of approved data/documents via secure and encrypted platforms after signing the agreement.
In total, depending on the completeness of the submitted documents, the process typically takes 3 to 6 weeks.
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Comments
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